{
  "url": "https://openlegislation.uk/blood-safety-and-quality-regulations-2005/regulation-8",
  "json_url": "https://openlegislation.uk/blood-safety-and-quality-regulations-2005/regulation-8.json",
  "legislation": "uksi/2005/50",
  "legislation_title": "The Blood Safety and Quality Regulations 2005",
  "legislation_url": "https://openlegislation.uk/blood-safety-and-quality-regulations-2005",
  "path": "regulation/8",
  "kind": "regulation",
  "number": "8",
  "heading": "Labelling of blood and blood components and traceability",
  "text": "(1) A blood establishment shall ensure that the label on each unit of blood or blood component supplied by it, or imported by it from a third country, shall contain the following information—\n(a) the official name of the component;\n(b) the volume or weight or number of cells in the component, as appropriate;\n(c) a unique numeric or alphanumeric donation indication;\n(d) the name of the producing blood establishment;\n(e) the ABO Group, except in the case of plasma intended only for fractionation;\n(f) the Rh D Group, either Rh D positive or Rh D negative, except in the case of plasma intended only for fractionation;\n(g) the date or time of expiry, as appropriate;\n(h) the temperature of storage;\n(i) the name, composition and volume of any anticoagulant and any additive solution.\n(2) A blood establishment shall maintain, in relation to all blood and blood components collected or prepared by it (including blood and blood components which are imported by it from a third country)—\n(a) records of the information referred to in paragraph (1) above;\n(b) the records referred to in Part A of Part 6 to the Schedule; and\n(c) such other records as are necessary to ensure full traceability of blood and blood components and identification of each single donation, unit and component.\n(3) The records referred to in sub-paragraph (a) of paragraph (2) shall be maintained—\n(a) in an appropriate and readable storage medium, and\n(b) for a period of not less than 30 years.\n(4) A blood establishment shall ensure that the traceability system in place in the blood establishment enables the tracing of blood and blood components to their location and processing stage.\n(5) A blood establishment shall have in place a system to uniquely identify each donor, each blood unit collected and each blood component prepared, whatever its intended purpose, and the facilities to which a given unit of blood or blood component has been delivered.”.\n(6) A blood establishment shall ensure, when it issues a unit of blood or blood components for transfusion, that the facility to which the unit of blood is issued has in place a procedure to verify that each unit of blood issued has been transfused to the intended recipient or, if not transfused, to verify its subsequent disposition.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 8(1) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 8(a); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 8(2) substituted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 5(2)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 8(2) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 8(b); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 8(3)-(6) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 5(3)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 8(3) inserted (1.5.2008) by The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (S.I. 2008/941), regs. 1(1), 7"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2005/50/regulation/8",
    "retrieved_at": "2026-10-29T05:11:46.706072+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}